Devices & Diagnostics Letter

Safety and industry experts are questioning a study that claims the device regulatory system in Europe is as safe as in the U.S., despite the EU’s reputation for putting devices in the market faster.

Electroconvulsive therapy (ECT) device manufacturers may pull their devices off the U.S. market if the FDA decides to back an advisory panel suggestion to formally classify ECT machines as Class III.

Sen. Scott Brown (R-Mass.) has introduced a bill that would repeal the $20 billion device tax in the healthcare reform bill and differs from other legislative efforts to strike down the tax by offering a funding alternative.

As talks to reauthorize the Medical Device User Fee and Modernization Act (MDUFMA) get underway, the device industry plans to request new metrics to ensure more timely processing of 510(K) and PMA submissions.

Constant litigation and regulatory setbacks took their toll on Boston Scientific’s annual and quarterly earnings last year, and 2011 is expected to be a tough year of transition.

Syneron has received an FDA warning letter for good manufacturing practice violations regarding its skin-tightening device, which it sold without clearance or premarket approval.

Volcano Corp. must pay St. Jude subsidiary LightLab $400,000 after it violated competition laws in Massachusetts, a Superior Court ruling says.

Johnson & Johnson (J&J) must pay $482 million to a New Jersey doctor for infringing a patent on devices to prop open heart arteries, a Texas court ruled.

Two institutional review boards (IRBs) have received warning letters for failure to follow written procedures and maintain member quorums during clinical trials for devices.

The FDA has issued a draft guidance on the required content and format of applications for the drugs used in positron emission tomography (PET) diagnostic scans.

Devicemakers nervous about seeing their executives targeted for criminal prosecution under the FDA’s stepped-up enforcement campaign based on the Park doctrine have received some insight into the factors the agency considers when pursuing such cases.

Medical device reports (MDRs) have increased 65 percent last year, and warning letters citing MDR procedures are on the rise as well.